GLP Regulatory Studies for Pharma & Biotech
Human and animal healthFull-Spectrum Expertise Across All Therapeutic Modalities
CER Groupe supports the full spectrum of modern drug development, from small molecules and biologics (ADC, recombinant proteins) to oligonucleotides (ASO), vaccines.
Our preclinical toxicology expertise also extends to emerging modalities including exosomes, extracellular vesicles (EVs), TEP, and advanced therapy medicinal products (ATMP, GTMP, CBMP).
Toxicology & Safety Studies- A Full Regulatory Spectrum
CER Groupe offers a comprehensive range of toxicology and safety studies, covering every stage of development:
- Early exploratory studies: DRF, MTD, NOAEL (non-GLP)
- Regulatory studies: single- and repeated-dose toxicity (ICH M3(R2), ICH S6), chronic toxicity (ICH S1/S6)
- Specialty studies: safety pharmacology (ICH S7A/S7B), reprotoxicity & developmental toxicity (ICH S5(R3)), tumorigenicity/carcinogenicity (ICH S1, S6)
- Additional assessments : recovery and satellite groups, immunogenicity
Species & Routes of Administration
Our studies are conducted across a wide range of species, covering all major preclinical models relevant to your program:
- mouse, rat, dog, rabbit, guinea pig, mini-pig and pig
All major routes of administration are supported - IP, IM, IV, IT, IN, oral and dermal.
PK, TK & ADME - From Exposure to Biodistribution
Understanding the absorption, distribution, metabolism, and excretion of your compound is critical at every stage of preclinical development. CER Groupe provides integrated PK/TK and ADME support across species, in GLP conditions upon request.
- ADME & biodistribution
- Toxicokinetics & pharmacokinetics
- Bioanalysis & exposure confirmation - LC-MS/MS
Readouts
- Clinical signs, body weight, food consumption
- Ophthalmology
- Hematology, clinical chemistry, coagulation
- Organ weights, gross pathology, histopathology
- Behavioral testing, pain assessment